Skip to main content
OpenTrials
Completed

NCT Number: NCT04373109

Stroke Rehabilitation Outcome During COVID-19 Lockdown

COVID-19 has a big impact on individuals and society as a whole. Especially persons with (multiple) comorbidities such as stroke are affected. The impact of COVID-19 on stroke rehabilitation delivery and stroke patients' functioning is unclear.

Completed

Looking for future studies?

Notify Me

Key information

About this study

With 16'000 patients hospitalized and with new permanent disability in approximately 7'000 individuals every year in Switzerland, stroke has a major impact on quality of life and is an enormous socioeconomic burden. Virtually all patients receive inpatient rehabilitation in the sub-acute phase poststroke. However, also in the later phases poststroke, patients receive rehabilitation interventions in outpatient rehabilitation clinics and private practices, with goal to improve or maintain their functional capacity.

Currently, Switzerland finds itself in an extraordinary situation. The Federal Council has issued a series of measures aimed at the population, organizations and institutions, and the cantons. The aim is to curb the spread of the coronavirus and assure the provision of healthcare. The people are invoked to stay at home and only leave the home if absolutely necessary. If they are over the age of 65 or have an underlying medical condition, the Federal Council strongly recommend that you stay at home under any circumstances unless you have to go to the doctor.

With the recommendation of the Swiss Federal Council almost all stroke patients belong to the group who should stay home. Furthermore, all outpatient rehabilitation clinics have reduced the interventions to a minimum. It is unknown how a sudden stop of rehabilitation influences the stroke patients' functional capacities and their perceived quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ischemic or haemorrhagic stroke, confirmed by MRI-DWI and/or CT
  • Participating in a stroke research project before the Lockdown (ESTREL - BASEC Nr. 2018-02021/ RE-USE - BASEC-Nr. 2017-01070)
  • Age 18 years or older
  • Verbal and written informed consent of the patient after participants' information

Exclusion criteria

  • Severe communication or cognitive deficits, that cause inability to follow the procedures

Treatment and study plan

observation

Behavioral

Observation of intensity of rehabilitation therapy, daily life upper limb use, physical activi-ty engagement, patient-reported quality of life, and motor outcome after stroke

Primary outcomes

  1. Rehabilitation data

    Time frame: 3 month after start lockdown

    Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions

  2. Motor Activity Log - 14 Item Version

    Time frame: 3 month after start lockdown

    Patient-reported upper limb use in daily life

  3. International Physical Activity Questionnaire

    Time frame: 3 month after start lockdown

    Patient-reported engagement in physical activity in daily life

  4. Patient-Reported Outcomes Measurement Information System - 29 Version

    Time frame: 3 month after start lockdown

    Patient-self-assessment comprising the following categories: 1) physical function, 2) anxiety, 3) depression, 4) fatigue, 5) sleep disturbance, 6) ability to participate in social roles and activities, 7) pain interference and 8) pain intensity

Secondary outcomes

  1. Global Rating of Perceived Changes (physical activity engagement and upper limb use)

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Patient-reported global rating of physical activity engagement and upper limb use in daily life

  2. Fatigue Severity Scale

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Self-reported questionnaire regarding severity of fatigue and its influence on the performance of daily life activities

  3. Hospital Anxiety and Depression Scale

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Depression and anxiety

  4. Montreal Cognitive Assessment

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Assesses cognitive functions

  5. Functional Ambulation Categories

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Classification regarding the ability to walk independently, with or without a walking aid and takes the type of walking surface into account

  6. Ten-Meter Walk Test

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Gait speed and cadence

  7. Rivermead Mobility Index

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Measures the ability of patients to make postural adjustments (e.g, move in bed), transfer (e.g. be-tween bed to chair), walk, and use stairs

  8. Activities-specific Balance Confidence Scale

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Self-reported measure in which patients rate how confident they are in maintaining balance when performing 16 daily life tasks

  9. Fugl-Meyer Motor Assessment

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Upper and lower limb motor function

  10. Action Research Arm Test

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Upper limb capacity

  11. modified Rankin Scale

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Global disability

  12. National Institutes of Health Stroke Scale

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 3 months after lockdown, 6 months after lockdown

    Neurological impairments

  13. Rehabilitation data

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown

    Nature of rehabilitation therapy, and number and duration of rehabilitation therapy sessions

  14. Motor Activity Log - 14 Item Version

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown

    Patient-reported upper limb use in daily life

  15. International Physical Activity Questionnaire

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown

    Patient-reported engagement in physical activity in daily life

  16. Patient-Reported Outcomes Measurement Information System - 29 Version

    Time frame: 4 weeks after lockdown ("extraordinary situation" as defined by the Swiss law), 6 months after lockdown

    Patient-self-assessment comprising the following categories: 1) physical function, 2) anxiety, 3) depression, 4) fatigue, 5) sleep disturbance, 6) ability to participate in social roles and activities, 7) pain interference and 8) pain intensity

Sponsors and collaborators

Lead sponsor

Jeremia Held

Other

Registry information

Acronym: SROCL

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 4, 2020
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.